AdvantimRecalls & reported problems across all models
Microport Orthopedics Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls
- 0
We found 11 models of Advantim by Microport Orthopedics Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Jan 14, 2015 and Jun 21, 2024 — classified as 45 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (20 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Advantim problems
Device problems
- Loss of Osseointegration20
- Device Dislodged or Dislocated12
- Insufficient Device Problem Information10
- Break3
- Adverse Event Without Identified Device or Use Problem2
- Corroded2
- Migration2
- Unstable2
Patient problems
- Pain19
- No Information9
- Insufficient Information7
- Unspecified Infection6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Bone Fracture(s)2
- Hip Fracture2
- Failure of Implant1
Advantim models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Advantim 18080302Screw, Fixation, Bone19 reports
- Advantim 18080301Screw, Fixation, Bone6 reports
- Advantim 18080303Screw, Fixation, Bone6 reports
- Advantim 18080300Screw, Fixation, Bone4 reports
- Advantim 18080305Screw, Fixation, Bone3 reports
- Advantim 18080304Screw, Fixation, Bone2 reports
- ADVANTIM® 18720520Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- ADVANTIM® 18720713Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- ADVANTIM® 18800210Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- ADVANTIM® 18802300Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- ADVANTIM® 18903310Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent Advantim adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 21, 2024Naturally Worn; Naturally Worn
ALLEGEDLY, PATIENT UNDERWENT R TKR IN 2013. REVISED ON (B)(6) 2024 DUE TO WORN POLY. PATELLA RESURFACED AT THE SAME TIME. (B)(6).
Patient problems: Insufficient Information
MAUDE report 19585870 ↗InjuryApr 4, 2023Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT UNDERWENT IN (B)(6) 2010 REPLACEMENT OF THE RIGHT HIP BY MEANS OF A METAL-METAL PROSTHESIS IMPLANTATION, HAS DEVELOPED PSEUDO-TUMOR FROM METAL-METAL COUPLING, WITH EVIDENCE OF A COBALT DOSAGE OF 7.7 MG / L (COMPARED TO REFERENCE <1.0MG / L), CAUSING ASEPTIC LOOSENING OF THE PROSTHESIS AND FORCING IT TO UNDERGO A PROSTHETIC REVISION IN 2014, OF INCREASED COMPLEXITY DUE TO THE PRESENCE OF THE TUMOR MASS. MORE TOOLS SINCE THE ONSET OF METALLOSIS AND, EVEN MORE SO, THE DEVELOPMENT OF PSEUDO-TUMOR REPRESENT CLEAR TYPICAL CONSEQUENCES OF METAL-METAL COMBINATIONS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: ALLEGEDLY, REPORTED THE ONSET OF LOW-GRADE FEVER, INFECTIOUS CAUSES EXCLUDED. REPORTED GROIN PAIN WITH POAS WEAKNESS FOR ABOUT 1 YEAR. A CLINICAL ANALYSIS WITH ACCEPTANCE DATE OF (B)(6) 2014 SHOWS RESULTS OF P-CHROME 0.4 UG/L AND SG-COBALT 7.7UG/L. CLINICAL RECORDS SHOWED THAT THE DATE OF THE INTERVENTION FOR REVISION SURGERY WAS ON (B)(6) 2014. A MUSCLE-TENDON ULTRASOUND WITH DATE OF (B)(6) 2014 FOR THE RIGHT HIP, A CT PELVIS/SACROILIAC WITH DATE OF (B)(6) 2014 FOR THE RIGHT HIP AND OTHER STUDIES ARE FOUND FROM PAGES NUMBER 71 TO 77 IN THE FILE "DOC. 05 CARTELLA
Patient problems: Pain
MAUDE report 16678229 ↗InjuryNov 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT DISLOCATED 1-2 WEEKS AFTER SURGERY THE SOFT TISSUES WERE VERY LAX REQUIRED ZIMMER CONSTRAINED.
Patient problems: Failure of Implant
MAUDE report 15824553 ↗InjurySep 14, 2022Break; Loss of Osseointegration; Break; Loss of Osseointegration
ALLEGEDLY, ON (B)(6) 2012, PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HIS BODY IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY (THA). PATIENT'S (B)(6) 2012 HIP IMPLANT SURGERY WAS PERFORMED AT GEISINGER BLOOMSBURG HOSPITAL, BLOOMSBURG, PENNSYLVANIA. AFTER HIS INITIAL RECOVERY FROM THE (B)(6) 2012, HIP SURGERY, FOR SEVERAL YEARS PATIENT'S WRIGHT MEDICAL ARTIFICIAL HIP PERFORMED AS EXPECTED, AND THE PAIN AND DISABILITY PATIENT HAD EXPERIENCED IN HIS RIGHT HIP PRIOR TO HIS (B)(6) 2012, HIP REPLACEMENT SURGERY HAD BEEN SUBSTANTIALLY RELIEVED. ON OR ABOUT (B)(6) 2020 PATIENT WAS TOLD THAT HE SUFFERED A BROKEN SCREW HOLDING THE DYNASTY CUP, LEADING TO MECHANICAL LOOSENING OF THE CUP AND RIGHT HIP PAIN, AND THAT IT WAS ADVISABLE THAT HE UNDERGO SURGERY TO REMOVE THE DYNASTY CUP AND SCREWS AND REPLACE AND REFIX THE CUP AND FIXATION SCREWS(IT IS NOT INDICATED WHICH SCREW WAS BROKEN SINCE PATIENT HAD 3 SCREWS IMPLANTED. ALSO, IT HAS NOT BEEN INDICATED WHICH CUP AND SCREWS WERE USED TO REPLACE THE DYNASTY CUP AND SCREWS). WHILE REPLACING THE AFOREMENTIONED CUP ON (B)(6) 2020, SURGEON OBSERVED THAT THE PROFEMUR®PLUS COCR MODULAR NECK WAS WELL CONNECTED TO THE C
Patient problems: Pain
MAUDE report 15417888 ↗InjurySep 14, 2022Break; Loss of Osseointegration; Break; Loss of Osseointegration
ALLEGEDLY, ON (B)(6) 2012, PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HIS BODY IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY (THA). PATIENT'S (B)(6) 2012 HIP IMPLANT SURGERY WAS PERFORMED AT (B)(6) HOSPITAL, (B)(6). AFTER HIS INITIAL RECOVERY FROM THE (B)(6) 2012, HIP SURGERY, FOR SEVERAL YEARS PATIENT'S WRIGHT MEDICAL ARTIFICIAL HIP PERFORMED AS EXPECTED, AND THE PAIN AND DISABILITY PATIENT HAD EXPERIENCED IN HIS RIGHT HIP PRIOR TO HIS (B)(6) 2012, HIP REPLACEMENT SURGERY HAD BEEN SUBSTANTIALLY RELIEVED. ON OR ABOUT (B)(6) 2020 PATIENT WAS TOLD THAT HE SUFFERED A BROKEN SCREW HOLDING THE DYNASTY CUP, LEADING TO MECHANICAL LOOSENING OF THE CUP AND RIGHT HIP PAIN, AND THAT IT WAS ADVISABLE THAT HE UNDERGO SURGERY TO REMOVE THE DYNASTY CUP AND SCREWS AND REPLACE AND REFIX THE CUP AND FIXATION SCREWS(IT IS NOT INDICATED WHICH SCREW WAS BROKEN SINCE PATIENT HAD 3 SCREWS IMPLANTED. ALSO, IT HAS NOT BEEN INDICATED WHICH CUP AND SCREWS WERE USED TO REPLACE THE DYNASTY CUP AND SCREWS). WHILE REPLACING THE AFOREMENTIONED CUP ON (B)(6) 2020, SURGEON OBSERVED THAT THE PROFEMUR®PLUS COCR MODULAR NECK WAS WELL CONNECTED TO THE CONSERVE® NECK SLEEVE, BUT EASILY
Patient problems: Pain
MAUDE report 15417619 ↗InjurySep 13, 2022Break; Loss of Osseointegration; Break; Loss of Osseointegration
ALLEGEDLY, ON (B)(6) 2012, PATIENT HAD A WRIGHT MEDICAL ARTIFICIAL HIP IMPLANTED IN THE RIGHT SIDE OF HIS BODY IN A PROCEDURE KNOWN AS A TOTAL HIP ARTHROPLASTY (THA). PATIENT'S (B)(6) 18, 2012 HIP IMPLANT SURGERY WAS PERFORMED AT (B)(6) HOSPITAL, (B)(6). AFTER HIS INITIAL RECOVERY FROM THE (B)(6) 2012, HIP SURGERY, FOR SEVERAL YEARS PATIENT'S WRIGHT MEDICAL ARTIFICIAL HIP PERFORMED AS EXPECTED, AND THE PAIN AND DISABILITY PATIENT HAD EXPERIENCED IN HIS RIGHT HIP PRIOR TO HIS (B)(6) 2012, HIP REPLACEMENT SURGERY HAD BEEN SUBSTANTIALLY RELIEVED. ON OR ABOUT (B)(6) 2020 PATIENT WAS TOLD THAT HE SUFFERED A BROKEN SCREW HOLDING THE DYNASTY CUP, LEADING TO MECHANICAL LOOSENING OF THE CUP AND RIGHT HIP PAIN, AND THAT IT WAS ADVISABLE THAT HE UNDERGO SURGERY TO REMOVE THE DYNASTY CUP AND SCREWS AND REPLACE AND REFIX THE CUP AND FIXATION SCREWS(IT IS NOT INDICATED WHICH SCREW WAS BROKEN SINCE PATIENT HAD 3 SCREWS IMPLANTED. ALSO, IT HAS NOT BEEN INDICATED WHICH CUP AND SCREWS WERE USED TO REPLACE THE DYNASTY CUP AND SCREWS). WHILE REPLACING THE AFOREMENTIONED CUP ON (B)(6) 2020, SURGEON OBSERVED THAT THE PROFEMUR®PLUS COCR MODULAR NECK WAS WELL CONNECTED TO THE CONSERVE® NECK SLEEVE, BUT EA
Patient problems: Pain
MAUDE report 15414563 ↗InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE ACETABULAR COMPONENT WAS INSERTED AS A REVISION FOR A PREVIOUSLY MIGRATED PROCOTYL L SHELL. REVISION COMPONENT INSERTED IN ROUTINE FASHION AND SECURED WITH 3X SCREWS. SHELL INSERTION AND SCREW INSERTION APPEARED SECURE AT COMPLETION OF PROCEDURE. PATIENT SEEN IN ROUTINE FOLLOW UP CLINIC AT 3 MONTHS JUST 2 DAYS BEFORE READMISSION WITH FURTHER MIGRATION OF REVISION ACETABULAR COMPONENT. PATIENT DENIES ANY TRAUMATIC EVENT. THE PREVIOUS REVISION IS CAPTURED UNDER INCIDENT GROUP (B)(4). ADDITIONAL INFORMATION ON 18 AUG. 2022: ALLEGEDLY, AS REPORTED FROM (B)(6) REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15351240 ↗InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE ACETABULAR COMPONENT WAS INSERTED AS A REVISION FOR A PREVIOUSLY MIGRATED PROCOTYL L SHELL. REVISION COMPONENT INSERTED IN ROUTINE FASHION AND SECURED WITH 3X SCREWS. SHELL INSERTION AND SCREW INSERTION APPEARED SECURE AT COMPLETION OF PROCEDURE. PATIENT SEEN IN ROUTINE FOLLOW UP CLINIC AT 3 MONTHS JUST 2 DAYS BEFORE READMISSION WITH FURTHER MIGRATION OF REVISION ACETABULAR COMPONENT. PATIENT DENIES ANY TRAUMATIC EVENT. THE PREVIOUS REVISION IS CAPTURED UNDER INCIDENT GROUP (B)(4). ADDITIONAL INFORMATION: ALLEGEDLY, AS REPORTED FROM UK NJR REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15351222 ↗InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, THE ACETABULAR COMPONENT WAS INSERTED AS A REVISION FOR A PREVIOUSLY MIGRATED PROCOTYL L SHELL. REVISION COMPONENT INSERTED IN ROUTINE FASHION AND SECURED WITH 3X SCREWS. SHELL INSERTION AND SCREW INSERTION APPEARED SECURE AT COMPLETION OF PROCEDURE. PATIENT SEEN IN ROUTINE FOLLOW UP CLINIC AT 3 MONTHS JUST 2 DAYS BEFORE READMISSION WITH FURTHER MIGRATION OF REVISION ACETABULAR COMPONENT. PATIENT DENIES ANY TRAUMATIC EVENT. THE PREVIOUS REVISION IS CAPTURED UNDER INCIDENT GROUP (B)(6). ADDITIONAL INFORMATION: ALLEGEDLY, AS REPORTED FROM UK NJR REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 15351216 ↗InjuryAug 30, 2022Migration; Migration
ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENTS NOT REVISED: PRODUCT: PROFEMUR® L HIP STEM SIZE 5 HA COATED, PRODUCT ID: PHA05510, LOT#:1674917, QTY:1; PRODUCT: PROFEMUR® NECK A/R 8DGLONG COBALT CHROME, PRODUCT ID: PHAC1234, LOT#:1830376 QTY:1; REVISION NJR NUMBER: 4840985; SIDE:L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION ON 07/05/2022: POST OP X-RAY INDICATED THERE WAS POSSIBLY A NEED FOR REVISION. THE REVISION WAS CONDUCTED 8 (EIGHT) DAYS LATER. ACCORDING TO THE X-RAY THE PROCOTYL L WAS SPIN OUT, BUT THERE ARE NOT COPIES OF THIS X-RAY. WE RECEIVED TWO NEW PARTS WHICH BELONG TO SCREWS.
Patient problems: Insufficient Information
MAUDE report 15325010 ↗InjuryAug 30, 2022Migration; Migration
ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENTS NOT REVISED: PRODUCT:PROFEMUR® L HIP STEM SIZE 5 HA COATED PRODUCT ID: PHA05510 LOT#:1674917 QTY:1 PRODUCT:PROFEMUR® NECK A/R 8DGLONG COBALT CHROME PRODUCT ID: PHAC1234 LOT#:1830376. QTY:1. REVISION NJR NUMBER: 4840985. SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. ADDITIONAL INFORMATION ON 07/05/2022: POST OP X-RAY INDICATED THERE WAS POSSIBLY A NEED FOR REVISION. THE REVISION WAS CONDUCTED 8 (EIGHT) DAYS LATER. ACCORDING TO THE X-RAY THE PROCOTYL L WAS SPIN OUT, BUT THERE ARE NOT COPIES OF THIS X-RAY. WE RECEIVED TWO NEW PARTS WHICH BELONG TO SCREWS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 15324945 ↗InjuryAug 16, 2022Corroded
ALLEGEDLY, THE PATIENT ON (B)(6) 2020 HAD A LEFT REVISION SURGERY DUE TO CORROSION, ON (B)(6) 2020 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION ON THE SIDE LEFT.
Patient problems: Unspecified Infection
MAUDE report 15233387 ↗InjuryAug 16, 2022Corroded
ALLEGEDLY, THE PATIENT ON (B)(6) 2020 HAD A LEFT REVISION SURGERY DUE TO CORROSION, ON (B)(6)2020 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION ON THE SIDE LEFT.
Patient problems: Unspecified Infection
MAUDE report 15233292 ↗InjuryMar 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
PT. DISLOCATED. REVISED CUP (REPOSITIONED). PRODUCT NO REVISED: PRODUCT ID: PHAPE242 PROFEMUR Z 6 LONG VARUS STEM, LOT: 1906933, QTY: 1.
Patient problems: Insufficient Information
MAUDE report 13970732 ↗InjuryDec 22, 2021Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration
Other Microport Orthopedics Inc. products
All Microport Orthopedics Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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